Urgency Urinary IncontinenceNCT02833402
Sacral Neuromodulation and the Microbiome
An observational study of Urgency Urinary Incontinence, run by Northwestern University at 1 site in United States.
Trial summary
Sacral neuromodulation (SNM) which is approved as a treatment for men and women with urgency urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal incontinence, is a procedure designed to deliver electrical pulses to the sacral nerves, thereby influencing the bladder, sphincters, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urgency Urinary Incontinence
- What is being tested?
- InterStim Therapy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women over the age of 18 with UUI planning to undergo placement of a sacral nerve modulator will be included if they have at least 2 UUI episodes on a 3-day diary.
Who may be able to join
- Women over the age of 18 with UUI planning to undergo SNM implantation will be included if they have at least 2 UUI episodes on a baseline 3-day diary.
- Willing and able to complete study visits, questionnaires and diaries
- Women previously treated with OAB medication are permitted to participate, but must be off of all medications for a minimum of 4 weeks prior to the performance of the baseline 3-day bladder diary and baseline assessments. They will be required to stay off any OAB medications for the duration of the study.
Who cannot join
- Neurologic disease (including multiple sclerosis, spinal cord injury, history of cerebrovascular accident, significant peripheral neuropathy)
- Pregnancy
- History of recurrent UTI in last 6 months by definition (3 culture proven UTI in 1 year or 2 culture proven UTI in 6 month period), or women who are receiving treatment for recurrent UTI
- Prolapse beyond the hymen
- Other contraindication to SNM
- Microscopic hematuria, as defined as 3 or more RBC/hpf on complete microscopic urinary analysis, without appropriate work-up (renal imaging and cystoscopy)
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- History of pelvic radiation
- History of previous neuromodulation therapy including intravesical botulinum toxin, sacral neuromodulation or peripheral tibial nerve stimulation.
- Deferral Criteria:
- Recent systemic antibiotic exposure (within the past 4 weeks)
- Urinary Tract Infection (UTI) at time of enrollment or sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between the Urinary Microbiome and Response to Sacral Neuromodulation in Women With Urgency Urinary Incontinence
Sacral neuromodulation (SNM) which is approved as a treatment for men and women with urgency urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal incontinence, is a procedure designed to deliver electrical pulses to the sacral nerves, thereby influencing the bladder, sphincters, and pelvic floor. Although the success rates of this treatment are quite high, the precise mechanism of action of SNM in subjects with UUI remains unclear. Moreover, there are little data regarding specific patient characteristics that may serve as "predictors" for SNM success. Recent studies suggest that the bacterial community that lives in the urinary tract plays a role in the development and continuation of urinary symptoms. It is proposed that the urinary microbiome may change in women before and after SNM implantation and this study aims to describe these changes. Investigators in this study also hope to determine if differences in the urinary microbiome exist in women with a positive response to SNM treatment (responders) compared to those without symptom improvement (non-responders). This hypothesis will be tested by collecting urine samples as well as questionnaire and medical data from subjects with UUI that are already planning on undergoing SNM as part of clinical care before and after their SNM treatment.
Read the detailed description
One in four women reports bothersome symptoms of a pelvic floor disorder with 16% reporting urinary incontinence (UI). Sacral neuromodulation (SNM) which is approved for men and women with urgency urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal incontinence, is a procedure designed to deliver electrical pulses to the sacral nerves, thereby influencing the bladder, sphincters, and pelvic floor. SNM provides symptomatic relief in 70-86% of patients undergoing the procedure for UUI according to several recent prospective studies. Although the success rates are quite high, the precise mechanism of action of SNM in subjects with UUI remains unclear. Moreover, there are little data regarding specific patient characteristics that may serve as "predictors" for SNM success.
The microbiome refers to the genetic material of the micro-organisms present in a particular environment. The role of the microbiome has recently been implicated in several disease states (obesity, inflammatory bowel disease, and functional bowel disease. Initially, the urinary microbiome was not a part of the "human microbiome project" as it was widely accepted that urine is sterile. However, recent studies have noted the presence of a urinary microbiota in adult women without clinical urinary tract infections. Furthermore, recent studies have shown that the urinary microbiome differs among women with UUI versus those without UUI and also among women with interstitial cystitis / painful bladder syndrome versus those without it. These studies suggest that the urinary microbiome plays a role in the development and continuation of urinary symptoms.
Because of the invasiveness of the SNM procedure, it would be helpful to have a way to predict treatment success. Investigators in this study propose that the urinary microbiome may change in women before and after SNM implantation and hope to describe these changes by conducting this study. Investigators also hope to determine if differences in the urinary microbiome exist in women with a positive response to SNM treatment (responders) compared to those without symptom improvement (non-responders). This hypothesis will be tested by collecting urine samples from subjects with UUI that are already planning on undergoing SNM as part of clinical care before and after their SNM treatment.
- Conditions
- Urgency Urinary Incontinence
- Being tested
- InterStim Therapy
- Keywords
- Sacral Neuromodulation, Urinary leakage, Urinary incontinence, Urinary microbiome
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterStim TherapyDevice
Also called Sacral Neuromodulation
Sacral Neuromodulation, delivered by the InterStim® System, offers long-term control of bladder control and bowel control symptoms through modulation of the nerves that help control the pelvic floor and lower urinary tract.
| Study group | Role | What they receive |
|---|---|---|
| UUI patients undergoing SNM | Urine specimens, questionnaire, and medical data will be collected from subjects that have UUI and are undergoing InterStim placement (SNM). Receives: Device: InterStim Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The abundance of bacteria associated with inflammatory processes in the urinary tract of women with a positive response to SNM (responders) versus those without symptom improvement (non-responders)
Measured: 3 months after SNM treatment treatment
Secondary outcomes (1)
Changes in the urinary microbial community of responders to SNM therapy
Measured: 3 months after initiating SNM treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urgency Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Urogynecologic Society, University of Pennsylvania, University of Missouri-Columbia, University of North Carolina, University of Washington, Saint Francis Hospital and Medical Center
- Responsible party
- Sponsor
- Investigators
- Margaret Mueller, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833402
- Sponsor's protocol ID
- STU00202669
- Status last verified
- Nov 2023
- First submitted
- 12 Jul 2016
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between the Urinary Microbiome and Response to Sacral Neuromodulation in Women With Urgency Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02833402
- Acronym / sponsor ID
- STU00202669
- Conditions
- Urgency Urinary Incontinence
- Keywords
- Sacral Neuromodulation, Urinary leakage, Urinary incontinence, Urinary microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Urogynecologic Society, University of Pennsylvania, University of Missouri-Columbia, University of North Carolina, University of Washington, Saint Francis Hospital and Medical Center
- Study start
- Dec 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sacral neuromodulation (SNM) which is approved as a treatment for men and women with urgency urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal incontinence, is a procedure designed to deliver electrical pulses to the sacral nerves, thereby influencing the bladder, sphincters, and pelvic floor. Although the success rates of this treatment are quite high, the precise mechanism of action of SNM in subjects with UUI remains unclear. Moreover, there are little data regarding specific patient characteristics that may serve as "predictors" for SNM success. Recent studies suggest that the bacterial community that lives in the urinary tract plays a role in the development and continuation of urinary symptoms. It is proposed that the urinary microbiome may change in women before and after SNM implantation and this study aims to describe these changes. Investigators in this study also hope to determine if differences in the urinary microbiome exist in women with a positive response to SNM treatment (responders) compared to those without symptom improvement (non-responders). This hypothesis will be tested by collecting urine samples as well as questionnaire and medical data from subjects with UUI that are already planning on undergoing SNM as part of clinical care before and after their SNM treatment.
Detailed description
One in four women reports bothersome symptoms of a pelvic floor disorder with 16% reporting urinary incontinence (UI). Sacral neuromodulation (SNM) which is approved for men and women with urgency urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal incontinence, is a procedure designed to deliver electrical pulses to the sacral nerves, thereby influencing the bladder, sphincters, and pelvic floor. SNM provides symptomatic relief in 70-86% of patients undergoing the procedure for UUI according to several recent prospective studies. Although the success rates are quite high, the precise mechanism of action of SNM in subjects with UUI remains unclear. Moreover, there are little data regarding specific patient characteristics that may serve as "predictors" for SNM success.
The microbiome refers to the genetic material of the micro-organisms present in a particular environment. The role of the microbiome has recently been implicated in several disease states (obesity, inflammatory bowel disease, and functional bowel disease. Initially, the urinary microbiome was not a part of the "human microbiome project" as it was widely accepted that urine is sterile. However, recent studies have noted the presence of a urinary microbiota in adult women without clinical urinary tract infections. Furthermore, recent studies have shown that the urinary microbiome differs among women with UUI versus those without UUI and also among women with interstitial cystitis / painful bladder syndrome versus those without it. These studies suggest that the urinary microbiome plays a role in the development and continuation of urinary symptoms.
Because of the invasiveness of the SNM procedure, it would be helpful to have a way to predict treatment success. Investigators in this study propose that the urinary microbiome may change in women before and after SNM implantation and hope to describe these changes by conducting this study. Investigators also hope to determine if differences in the urinary microbiome exist in women with a positive response to SNM treatment (responders) compared to those without symptom improvement (non-responders). This hypothesis will be tested by collecting urine samples from subjects with UUI that are already planning on undergoing SNM as part of clinical care before and after their SNM treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UUI patients undergoing SNM | – | Device: InterStim TherapyUrine specimens, questionnaire, and medical data will be collected from subjects that have UUI and are undergoing InterStim placement (SNM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women over the age of 18 with UUI planning to undergo placement of a sacral nerve modulator will be included if they have at least 2 UUI episodes on a 3-day diary.
Key inclusion criteria (3 listed)
- Women over the age of 18 with UUI planning to undergo SNM implantation will be included if they have at least 2 UUI episodes on a baseline 3-day diary.
- Willing and able to complete study visits, questionnaires and diaries
- Women previously treated with OAB medication are permitted to participate, but must be off of all medications for a minimum of 4 weeks prior to the performance of the baseline 3-day bladder diary and baseline assessments. They will be required to stay off any OAB medications for the duration of the study.
Key exclusion criteria (11 listed)
- Neurologic disease (including multiple sclerosis, spinal cord injury, history of cerebrovascular accident, significant peripheral neuropathy)
- Pregnancy
- History of recurrent UTI in last 6 months by definition (3 culture proven UTI in 1 year or 2 culture proven UTI in 6 month period), or women who are receiving treatment for recurrent UTI
- Prolapse beyond the hymen
- Other contraindication to SNM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterStim TherapyAlso: Sacral NeuromodulationSacral Neuromodulation, delivered by the InterStim® System, offers long-term control of bladder control and bowel control symptoms through modulation of the nerves that help control the pelvic floor and lower urinary tract. | Device | UUI patients undergoing SNM |
Primary outcome
The abundance of bacteria associated with inflammatory processes in the urinary tract of women with a positive response to SNM (responders) versus those without symptom improvement (non-responders)
Time frame: 3 months after SNM treatment treatment
1 secondary outcome
Changes in the urinary microbial community of responders to SNM therapy
Time frame: 3 months after initiating SNM treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Mueller, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urgency Urinary Incontinence, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The abundance of bacteria associated with inflammatory processes in the urinary tract of women with a positive response to SNM (responders) versus those without symptom improvement (non-responders) (time frame: 3 months after SNM treatment treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.